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510(k) Data Aggregation
K Number
K021493Device Name
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
Manufacturer
Date Cleared
2002-08-30
(113 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ANDERSEN PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Andersen® Nasogastric Tube is indicated in those situations where the physician desires to keep the stomach continuously and completely evacuated of swallowed air, swallowed saliva, gastric secretions or fresh blood in a fasting patient for a prolonged period, such as pancreatitis. cholecyctitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep the stomach evacuated of fresh blood once clots have been removed.
Device Description
Sterile, disposable, bilumenal, medical grade vinyl nasogastric tube with radiopaque vent tube, 24 round aspirating ports, and anti-reflux filter. Includes a lubricated polyethylene stylet. The tubes are marked to aid in positioning the tube during passage.
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K Number
K011077Device Name
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
Manufacturer
Date Cleared
2001-05-09
(30 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ANDERSEN PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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